FDA approves Corcept's Lifyorli for ovarian cancer months early

Women with platinum-resistant ovarian cancer have run out of effective options — and for years, the drugs that remained barely worked. That changes today with the FDA approval of Lifyorli, a first-in-class therapy from Corcept Therapeutics that demonstrated a 35 percent reduction in the risk of death compared with chemotherapy alone in a Phase 3 trial. The agency approved Lifyorli on March 25, more than three months ahead of schedule, an unusually early move that signals something real in the data.

Lifyorli (relacorilant) is the first FDA-approved selective glucocorticoid receptor antagonist — a drug that blocks cortisol from activating survival pathways that chemotherapy relies on apoptosis to overcome. In the ROSELLA trial of 381 patients who had already received up to three prior therapies, the combination of relacorilant plus nab-paclitaxel extended median overall survival to 16 months versus 11.9 months for nab-paclitaxel alone, a difference that cleared a p-value of 0.0004 — not a rounding error. Progression-free survival also improved, with a median of 6.5 months versus 5.5 months. The drug is taken orally the day before, day of, and day after each chemotherapy infusion.

"Platinum-resistant ovarian cancer has been one of the most stubborn problems in gynecologic oncology," said Dr. Rob Coleman, a gynecologic oncologist at Texas Oncology and a leader with the GOG Foundation. "Lifyorli plus nab-paclitaxel is positioned to become a new standard-of-care treatment for these patients."

The mechanism is worth understanding: cortisol activates survival signals in tumor cells, and chemotherapy depends on apoptosis to kill them. Relacorilant competitively blocks the glucocorticoid receptor — without touching progesterone, estrogen, or androgen receptors — effectively removing cortisol's protective effect when chemo is doing its work. Corcept has been in this biology since 2012, when it introduced Korlym (mifepristone) for Cushing's syndrome. That 14-year commercial track record in cortisol modulation is part of why the FDA moved on this application without delay.

The safety profile has a real asterisk. One patient died from septic shock with febrile neutropenia in the trial — Corcept calls it isolated, and the broader benefit-risk calculus clearly favored approval, but this is a population of women who are fragile and heavily pretreated. Thirty-eight percent of patients required a white blood cell booster during the first or second cycle. The most common adverse events — decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea — are manageable for most, but oncologists prescribing this will be managing real toxicity in real people.

ROSELLA enrolled patients across the United States, Europe, South Korea, Brazil, Argentina, Canada, and Australia through a collaboration involving the GOG Foundation, ENGOT, APGOT, LACOG, and ANZGOG. Results were first presented at the American Society of Clinical Oncology annual meeting in 2025 and simultaneously published in The Lancet. Complete data are scheduled for presentation at the Society of Gynecologic Oncology meeting in April.

Approximately 20,000 women in the United States with platinum-resistant ovarian cancer are candidates to start a new therapy each year, with at least an equal number in Europe — a defined and desperate population that has cycled through standard platinum-based chemotherapy, often including bevacizumab, and has nowhere else that works.

Joseph Belanoff, Corcept's chief executive, called the approval "an important first step, but there is much more to explore with this new mode of treatment." The company is studying relacorilant in additional combinations and cancer types, though no formal development announcements have been filed.

Corcept's stock surged approximately 32 percent on the approval announcement, pushing the company's market capitalization to roughly \$4 billion. For a firm whose prior commercial product addressed a rare endocrine condition, the Lifyorli approval is a substantial expansion of addressable population — and marks Corcept's entry into oncology in earnest.

The open questions are the ordinary ones for a newly approved drug: how quickly physicians adopt it, whether payors create friction with prior authorization requirements, and what the broader relacorilant development program looks like after the SGO data land in April. The OS result was the headline. The safety profile is manageable. And for the first time in a long time, women with platinum-resistant ovarian cancer have a therapy with a survival benefit that cleared a rigorous statistical bar.

https://endpoints.news/fda-approves-corcepts-lifyorli-for-ovarian-cancer-months-early/

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02825-7/fulltext

https://ir.corcept.com/news-releases/news-details/2026/Corcept-Therapeutics-Announces-FDA-Approval-of-RELYORLI-RELORLI-relacorilant-for-Platinum-Resistant-Ovarian-Cancer/default.aspx

https://www.reuters.com/business/healthcare-pharmaceuticals/corcept-ovarian-cancer-drug-wins-fda-approval-2026-03-25/